Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

September 20, 2023 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity

to compare the results of SASI to SAS-J in treatment of morbid obesity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study

Exclusion Criteria:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 60
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • revisional bariatric procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SASI
Procedure: SASI
Single-Anastomosis Sleeve ileal (SASI) Bypass
Experimental: SAS-J
Procedure: SAS-J
Single-Anastomosis Sleeve Jejunal (SAS-J) Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional deficiency
Time Frame: 12 months
the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comorbidities
Time Frame: 1 year
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
1 year
complications
Time Frame: 1 year
early and late complications
1 year
weight loss
Time Frame: 12 months
the effect of the 2 procedures on weight measured by percentage of excess weight loss
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

May 7, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med 22.26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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